Cardiovascular Diseases (CVD)wCAR-AustriaNCT07849127
wCAR-Austria: A Women-Specific Score to Assess Cardiovascular Risk in Women Aged 40 to 65
A study testing Arm 1: wCAR-CARE - Precision Prevention (Arm A) in people with Cardiovascular Diseases (CVD) and Coronary Artery Disease, run by Women's Heart Austria at 1 site in Austria.
Trial summary
The wCAR-Austria Study is a multicentre, prospective, interventional study evaluating a novel women-specific cardiovascular risk score (wCAR) in 800 women aged 40-65 years across Austria. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases (CVD), Coronary Artery Disease, Atheroscleroses
- What is being tested?
- Arm 1: wCAR-CARE - Precision Prevention (Arm A)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jan 2027to 31 Mar 2034
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged 40-65 years
- Pre-, peri-, or postmenopausal (including women with premature ovarian insufficiency and early menopause)
- Ability to provide written informed consent after thorough information
- Extended inclusion of women with type 2 diabetes, pre-diabetes, and familial hypercholesterolaemia
Who cannot join
- Known manifest atherosclerotic cardiovascular disease (prior myocardial infarction, coronary revascularisation, stroke)
- Pregnancy at the time of baseline visit
- eGFR < 30 ml/min/1.73 m² (KDIGO G4-G5)
- Advanced oncological disease with life expectancy < 3 years
- Known contrast agent allergy with anaphylactic reaction
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Steringer contact
Austria1 site
Anna Rab
Klagenfurt, 9020
Anna Rab, MD, +43 6767216660, anna.rab@icloud.com
About this study
Official title: Women's Cardiovascular Risk Score (wCAR) - Austria: A Multicentre Prospective Validation Study Using Photon-Counting Coronary CT Angiography, With the Randomised Interventional Substudy wCAR-CARE
The wCAR-Austria Study is a multicentre, prospective, interventional study evaluating a novel women-specific cardiovascular risk score (wCAR) in 800 women aged 40-65 years across Austria. The wCAR score integrates conventional and women-specific cardiovascular risk factors - including hypertensive disorders of pregnancy, gestational diabetes, premature ovarian insufficiency, autoimmune disease, and menopause stage - into a three-axis, multiplicatively modular architecture.
The study consists of two phases:
Read more
A randomised, controlled interventional substudy (wCAR-CARE, PROBE design) allocates all participants with wCAR ≥ 11 points 1:1 to a structured precision-prevention arm (arm A, including tailored lifestyle intervention, structured statin evaluation, and menopausal hormone therapy counselling within the "window of opportunity") versus guideline-directed standard of care (arm B) for 24 months.
Co-primary endpoints of Phase A are the area under the receiver-operating-characteristic curve (AUC) of the wCAR score for any coronary plaque (including non-calcified soft plaque on CCTA) in the intermediate stratum (E1a, n=100) and in the combined intermediate + high strata (E1b, n=200), analysed under a Bonferroni-Holm closed-testing procedure. The co-primary endpoint of wCAR-CARE is a composite risk-factor endpoint at month 24. The primary Phase B endpoint is time to first MACE.
Secondary endpoints include reclassification improvement of wCAR versus SCORE2 and PREVENT, convergence validation against age-adjusted NT-proBNP percentiles, and convergence validation against high-sensitivity troponin-T using sex-specific thresholds per the Fifth Universal Definition of Myocardial Infarction (Mills et al., 2026).
Read the detailed description
Background. Cardiovascular disease is the leading cause of death in women in Austria and worldwide, yet women are systematically under-recognised in cardiovascular risk assessment. Established risk scores such as SCORE2 and PREVENT do not adequately incorporate women-specific risk factors including hypertensive disorders of pregnancy, gestational diabetes, premature ovarian insufficiency (POI), autoimmune disease, elevated lipoprotein(a), or menopausal status. The women-specific cardiovascular risk score wCAR was developed to address this gap and integrates conventional and women-specific risk factors in a three-axis, multiplicatively modular architecture. In a monocentric pilot study of 107 women, wCAR showed an AUC of 0.66 for coronary artery calcium (CAC > 0) versus 0.52 for PREVENT-ASCVD.
Design. Multicentre, prospective, interventional two-phase study enrolling 800 women aged 40-65 across six Austrian centres.
Phase A - cross-sectional validation (12 months). All participants undergo clinical examination (blood pressure, height, weight, waist circumference - WHtR as primary adiposity indicator, BMI as secondary covariate), extended laboratory testing (lipid profile including Lp[a], HbA1c, fasting glucose for TyG-Index, creatinine/eGFR, hs-CRP, NT-proBNP with age- and sex-adjusted percentile referencing, hs-troponin-T with sex-specific thresholds per Fifth UDMI 2026, uric acid), validated questionnaires (Menopause Rating Scale, WHO-5, PHQ-9, Food Frequency Questionnaire), and calculation of wCAR, SCORE2, and PREVENT scores.
Coronary photon-counting CT angiography (CCTA) is performed in a stratified randomised subset of 250 participants:
This stratified sampling minimises cumulative radiation exposure while providing sufficient statistical power for the primary endpoints. Photon-counting CCTA delivers 1-3 mSv effective dose, comparable to natural annual background radiation. All images are centrally analysed by a core laboratory using CE-marked Siemens Healthineers software.
Phase B - prospective follow-up (3-5 years). Annual structured contact with all 800 participants; MACE ascertainment and adjudication by an independent endpoint committee blinded to treatment allocation.
wCAR-CARE interventional substudy. All Phase A participants with wCAR ≥ 11 points are randomised 1:1 to arm A (structured precision-prevention intervention including tailored lifestyle intervention with defined behaviour targets - 7,000 steps per day on at least 5 days per week, at least two structured strength-training sessions per week, at least 30 vegetable portions per week, added sugar less than 25 g per day, alcohol less than 100 g per week, 7-9 hours of sleep, non-smoking - structured statin evaluation, and MHT counselling within the "window of opportunity") versus arm B (guideline-directed standard of care). Intervention duration: 24 months. Co-primary endpoint E2: composite risk-factor endpoint at month 24 (achievement of at least one of: ≥ 1 wCAR class improvement, LDL-C reduction ≥ 15%, systolic blood pressure reduction ≥ 10 mmHg, TyG-Index reduction ≥ 10%, HbA1c reduction ≥ 0.3 percentage points in participants with pre-diabetes or T2DM).
EDC × Sugar substudy. In a stratified subsample of 200 participants, an exploratory analysis examines the association between endocrine-disrupting chemical exposure (urinary phthalate and bisphenol metabolites, optionally serum PFAS) and sugar consumption with coronary plaque status.
Statistical analysis. ROC analyses using DeLong's method for AUC comparisons; NRI and IDI with bootstrap confidence intervals; Cox proportional hazards regression; mixed models for longitudinal data. Convergence validation of wCAR against age-adjusted NT-proBNP percentiles and against sex-specific hs-troponin-T (Fifth UDMI 2026) across the entire cohort (n=800).
Ethics. Approved by the Ethics Committee of Carinthia (M2026-15, valid until 27 August 2027). Local ethics approvals for additional participating centres are pending.
Funding. Investigator-initiated trial funded through the Association's own resources and in-kind contributions from Siemens Healthcare Diagnostics GmbH (imaging equipment, analysis software, participant insurance). No public or private project funding in the form of monetary grants.
- Being tested
- Arm 1: wCAR-CARE - Precision Prevention (Arm A), Guideline-directed standard of care
- Keywords
- coronary artery calcium; NT-proBNP; menopause; sex-specific risk stratification; women's cardiovascular health; midlife, coronary artery calium, NT-proBNP, Menopause, sex-specific risk stratification, coronary artery calcium, women's cardiovascular health, midlife
- Medical subject headings
- Cardiovascular Diseases, Coronary Artery Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1: wCAR-CARE - Precision Prevention (Arm A)Behavioural
- Description: Structured, phenotype-adapted precision prevention including tailored lifestyle intervention (defined behaviour targets: 7,000 steps/day on ≥ 5 days/week, ≥ 2 structured strength-training sessions/week, ≥ 30 vegetable portions/week, added sugar < 25 g/day, alcohol < 100 g/week, 7-9 hours of sleep, non-smoking), structured statin evaluation per ESC 2021 guidelines, and menopausal hormone therapy counselling per EMAS 2021 / NAMS 2022 within the "window of opportunity" (< 10 years post-menopause). Follow-up contacts at M0, M1, M3, M6, M12, M18, M24.
Guideline-directed standard of careBehavioural
Guideline-directed cardiovascular prevention care delivered by the participant's regular treating physicians without structured additional intervention. Participants continue their usual care pathway as clinically indicated by their treating physician, without protocol-mandated lifestyle coaching, structured statin evaluation, or menopausal hormone therapy counselling. Study-related follow-up contacts occur at Month 0, 3, 6, 12, 18, and 24 for structured ascertainment of the co-primary composite risk-factor endpoint (E2) and its components, without influencing clinical management decisions.
| Study group | Role | What they receive |
|---|---|---|
| Structured, phenotype-adapted precision prevention including tailored lifestyle intervention (define | Experimental | • Intervention: Behavioural / Drug Receives: Behavioral: Arm 1: wCAR-CARE - Precision Prevention (Arm A) |
| Phase A cross-sectional characterisation without study-related intervention; participants with wCAR | No intervention | Not described |
| wCAR-CARE - Guideline-Directed Standard of Care (Arm B) | Active comparator | * Description: Guideline-directed cardiovascular prevention care delivered by the participant's regular treating physicians without structured additional intervention. Study-related follow-up contacts at M0, M3, M6, M12, M18, M24 for structured E2 component ascertainment.
* Intervention: Standard of Care Receives: Behavioral: Guideline-directed standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the ROC Curve (AUC) of the wCAR Score for Detecting Any Coronary Plaque on Photon-Counting CCTA in Women With Intermediate wCAR Risk (6-10 Points)
Discriminative performance of the women's cardiovascular risk (wCAR) total score for the presence of any coronary plaque (calcified, mixed or non-calcified) on photon-counting coronary computed tomography angiography (CCTA), with central core-lab image evaluation blinded to the wCAR score. Analysis population: study-mandated CCTA participants randomly sampled from the intermediate wCAR stratum (6-10 points, n=100). Reported as AUC with 95% confidence interval (ROC analysis, DeLong method; bootstrap confidence intervals). Co-primary with E1b; multiplicity controlled by Bonferroni-Holm closed testing. Protocol endpoint E1a.
Measured: At baseline (Phase A cross-sectional assessment)
Time to First Major Adverse Cardiovascular Event (MACE: Cardiovascular Death, Non-Fatal Myocardial Infarction, Non-Fatal Stroke or Coronary Revascularisation) by wCAR Risk Category
Prognostic value of the wCAR score for MACE in the total cohort (n=800). MACE is defined as the first occurrence of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or coronary revascularisation, adjudicated by an independent endpoint committee blinded to participant identity using pseudonymised clinical records. Reported as hazard ratio with 95% CI for wCAR categories R3/R4 versus R1/R2 (Cox proportional hazards regression) and Harrell's C-statistic; Kaplan-Meier estimates by wCAR risk category. Protocol endpoint Phase B.
Measured: Up to 5 years after baseline (minimum follow-up 3 years)
Percentage of Participants Achieving the Composite Risk-Factor Endpoint at Month 24 (wCAR Class Improvement or Reduction in LDL-C, Systolic Blood Pressure, TyG Index or HbA1c)
Binary composite endpoint, achieved if at least one of the following criteria is met at month 24 compared with baseline: (a) improvement by at least one wCAR risk class (e.g., very high to high); (b) LDL-C reduction of at least 15%; (c) systolic blood pressure reduction of at least 10 mmHg; (d) TyG index reduction of at least 10%; (e) HbA1c reduction of at least 0.3 percentage points (participants with prediabetes or type 2 diabetes only). Population: participants with wCAR score of 11 points or higher randomised 1:1 to Arm A (wCAR-guided precision prevention) or Arm B (guideline-based standard care). Endpoint assessment blinded to arm allocation (PROBE design). Reported as number and percentage of participants achieving the endpoint per arm; primary analysis by intention-to-treat using logistic regression adjusted for centre and wCAR stratum (risk difference and odds ratio with 95% CI). Protocol endpoint E2 (wCAR-CARE substudy).
Measured: 24 months after randomisation
Area Under the ROC Curve (AUC) of the wCAR Score for Detecting Any Coronary Plaque on Photon-Counting CCTA in Women With Intermediate or High wCAR Risk (6-15 Points)
Discriminative performance of the women's cardiovascular risk (wCAR) total score for the presence of any coronary plaque (calcified, mixed or non-calcified) on photon-counting coronary computed tomography angiography (CCTA), with central core-lab image evaluation blinded to the wCAR score. Analysis population: study-mandated CCTA participants randomly sampled from the intermediate (6-10 points, n=100) and high (11-15 points, n=100) wCAR strata (combined n=200). Reported as AUC with 95% confidence interval (ROC analysis, DeLong method; bootstrap confidence intervals). Co-primary with E1a; multiplicity controlled by Bonferroni-Holm closed testing. Protocol endpoint E1b.
Measured: At baseline (Phase A cross-sectional CCTA assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Diseases (CVD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Heart Austria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849127
- Sponsor's protocol ID
- M2026-15
- Acronym
- wCAR-Austria
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No